Current U.S. guidelines recommend integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) as initial treatment for people with HIV (PWH). We assessed long-term effects of INSTI use on lipid profiles in routine HIV care. We analyzed medical record data from the HIV Outpatient Study's participants in care from 2007 to 2021. Hyperlipidemia was defined based on clinical diagnoses, treatments, and laboratory results. We calculated hyperlipidemia incidence rates and rate ratios (RRs) during initial ART and assessed predictors of incident hyperlipidemia by using Poisson regression. Among 349 eligible ART-naïve PWH, 168 were prescribed INSTI-based ART (36 raltegravir (RAL), 51 dolutegravir (DTG), and 81 INSTI-others (elvitegravir and bictegravir)) and 181 non-INSTI-based ART, including 68 protease inhibitor (PI)-based ART. During a median follow-up of 1.4 years, hyperlipidemia rates were 12.8, 22.3, 22.7, 17.4, and 12.6 per 100 person years for RAL-, DTG-, INSTI-others-, non-INSTI-PI-, and non-INSTI-non-PI-based ART, respectively. In multivariable analysis, compared with the RAL group, hyperlipidemia rates were higher in INSTI-others (RR = 2.25; 95% confidence interval (CI): 1.29-3.93) and non-INSTI-PI groups (RR = 1.89; CI: 1.12-3.19) but not statistically higher for the DTG (RR = 1.73; CI: 0.95-3.17) and non-INSTI-non-PI groups (RR = 1.55; CI: 0.92-2.62). Other factors independently associated with hyperlipidemia included older age, non-Hispanic White race/ethnicity, and ART without tenofovir disoproxil fumarate. PWH using RAL-based regimens had lower rates of incident hyperlipidemia than PWH receiving non-INSTI-PI-based ART but had similar rates as those receiving DTG-based ART, supporting federal recommendations for using DTG-based regimens as the initial therapy for ART-naïve PWH.

Background:Persons with HIV (PWH) with end stage kidney disease (ESKD) who are eligible for kidney transplantation have post-transplantation outcomes similar to those without HIV infection. However, barriers to referral to care, evaluation, and receipt of transplants remain for PWH. We sought to identify PWH with ESKD or end stage liver disease (ESLD) who would be candidates for organ transplant and to review their clinical outcomes.Methods:We analyzed data from participants in the HIV Outpatient Study (HOPS) between 01-01-2009 and 06-30-2023, with a diagnosis of ESKD or ESLD. We identified a subset of PWH who would otherwise meet the general criteria for kidney or liver transplantation. Targeted clinical outcomes included dialysis, transplantation, and death.Results:Among 5,215 PWH in the HOPS, 258 with ESKD and 23 with ESLD would otherwise meet criteria for transplant. However, only 9 kidney and 2 liver transplants were performed.Conclusion:Low transplantation rates among eligible PWH may suggest timely referral to care and evaluation for kidney and liver transplantation often does not occur. Expanding access for PWH with ESKD to both deceased and living donor kidney allografts is needed. Kidney and liver transplant centers also need to seek ways to broaden access to eligible PWH with ESKD or ESLD. Copyright © 2024 Wolters Kluwer Health, Inc.

During 2007-2019, the percentage of HIV Outpatient Study participants reporting anal or vaginal condomless sex in the past 6 months ranged from a low of 17% among heterosexual males to 59% for men who have sex with men (MSM). MSM reported having had condomless sex more frequently than heterosexual males and females and were the only group in which an increase in condomless sex was observed during the study period (from 39 to 59%). Although persons with undetectable HIV viral load have effectively no risk of transmitting HIV sexually (U = U), there is still the potential risk of transmission or acquisition of other sexually transmitted infections (STIs) when engaging in condomless sex. Continuing education about risks of HIV and STI transmission as well as ongoing screening for and treatment of STIs, retention in HIV treatment, and support for sexual health are critical components of care for people living with HIV.

BACKGROUND: Suicidal ideation (SI) refers to an individual thinking about, considering or planning suicide. Identifying and characterizing persons with HIV (PWH) at greater risk for SI may lead to better suicide prevention strategies and quality of life improvement. METHODS: Using clinical data gathered from medical chart abstraction for HIV Outpatient Study (HOPS) participants from 2000 to 2017, we assessed SI frequency among PWH in care and explored factors associated with the presence of SI diagnoses using linear mixed models analyses of case-matched participants. RESULTS: Among 6706 participants, 224 (3.3%) had a charted diagnosis of SI. Among those with SI, median age (interquartile range [IQR]) was 43.4years [IQR: 38.7-50.3], median (IQR) CD4 count was 439 cells/mm(3) (IQR: 237-686), 71.4% were male, 54% were men who have sex with men (MSM), 25.4% heterosexual, and 13.4% persons who inject drugs. In multivariable analysis, persons at increased risk for SI were more likely to be: <50years old (adjusted rate ratio [aRR] 1.86, 95% confidence interval [95%CI] 1.36-2.53), non-Hispanic/Latino black (aRR 1.75; 95%CI 1.29-2.38), have CD4+ cell count <350 cells/mm(3) (aRR 1.32; 95%CI 1.05-1.65), have a viral load >/=50 copies/mL (aRR 1.49; 95%CI 1.12-1.98), have stopped antiretroviral therapy (aRR 1.46; 95%CI 1.10-1.95), have a history of: alcohol dependence (aRR 2.75; 95%CI 1.67-4.52), and drug overdose (aRR 4.09; 95%CI 2.16-7.71). CONCLUSION: Routine mental health assessment and monitoring are needed in HIV clinical practice to better understand factors associated with SI and to inform the development of preventive interventions.

In the United States, women accounted for 19% of new HIV diagnoses in 2015 and were less likely to reach virologic suppression when compared to men. We assessed trends and disparities in virologic suppression among HIV-positive women to inform HIV treatment strategies. Data were from a prospective cohort of the HIV Outpatient Study and collected at nine United States HIV clinics. We included women aged >/=18 years, with >/=1 visit, who were prescribed antiretroviral therapy, and had >/=1 viral load test performed between 2010 and 2015. We defined virologic suppression as viral load <50 copies/mL and calculated adjusted prevalence ratios (aPR) with 95% confidence intervals (CI) for virologic suppression by race/ethnicity and year of measure. Generalized estimating equations were used for multivariable analyses to assess factors associated with virologic suppression. Among 809 women (median age = 44 years), 482 (60%) were black, 177 (22%) white, 150 (19%) Hispanic/Latina. Virologic suppression was less prevalent among black women (73%) compared with Hispanic/Latina women (83%) and white women (91%). In multivariable analyses, not achieving virologic suppression was more likely among black women (aPR = 2.13; CI = 1.50-3.02) or Hispanic/Latina women (aPR = 1.66; CI = 1.08-2.56) compared with white women, and among women who attended public clinics (aPR = 1.42; CI = 1.07-1.87) compared with those who attended a private clinic. Between 2010 and 2015, virologic suppression among HIV-positive women increased from 68% to 83%, but racial/ethnic disparities persisted. Black and Hispanic/Latina women had significantly lower rates of virologic suppression than white women. Interventions targeting virologic suppression improvement among HIV-positive women of color, especially those who attend public clinics, are warranted.

Effective antiretroviral therapy (ART) reduces plasma HIV RNA viral load (VL) to undetectable levels and its effectiveness depends on consistent adherence. Consistent adherence and use of safe sex practices may substantially decrease the risk of HIV transmission. We sought to explore the potential association between self-reported nonadherence to ART and engaging in unsafe sexual practices capable of transmitting HIV. Using clinical and audio computer-assisted self-interview data from the prospective HIV Outpatient Study from 2007 to 2014, we assessed the frequency of self-reported ART nonadherence during the three days prior to the survey among HIV-infected persons in care and factors associated with self-reported ART nonadherence. Of 1729 patients included in this analysis (median age = 48 years, 74.3% men who have sex with men), 17% were nonadherent, 15% had a detectable VL, and 42% reported condomless anal or vaginal sex in the past six months. In multivariable analysis, self-reported nonadherence was independently associated with younger age (adjusted odds ratio [aOR] 0.8 per additional ten years, [95% CI] 0.7-1.0), non-Hispanic black race/ethnicity (aOR 1.9; 95% CI 1.4-2.6 versus white), public health insurance (aOR 1.6, 95% CI 1.2-2.3 compared with private), survey date in 2011-2014 versus 2007-2010 (aOR 0.7, 95% CI 0.5-0.9), CD4 cell count ≥ 500 versus < 200 cells/mm3 (aOR 0.3, 95% CI 0.2-0.5), greater number of ART regimen doses (aOR 1.6, 95% CI 1.3-2.2), and binge drinking (aOR 1.4, 95% CI, 1.1-1.9). In this analysis, self-reported nonadherence was not associated with engaging in condomless sex.

BACKGROUND: In the United States, sexually transmitted infection (STI) testing is recommended at least annually for sexually active men who have sex with men (MSM). We evaluated human immunodeficiency virus (HIV) providers' STI testing practices and frequency of positive test results. METHODS: We analyzed data from HIV Outpatient Study (HOPS) participants who, from 2007 to 2014, completed a confidential survey about risk behaviors. Using medical records data, we assessed the frequency of gonorrhea, chlamydia, and syphilis testing and positive results during the year after the survey for MSM who reported sex without a condom in the prior 6 months. We compared testing frequency and positivity for men having 1, 2 to 3, and 4 or more sexual partners. Correlates of STI testing were assessed using general linear model to derive relative risks (RR) with associated 95% confidence intervals (CI). RESULTS: Among 719 MSM, testing frequency was 74.5%, 74.3%, and 82.9% for gonorrhea, chlamydia, and syphilis, respectively, and was higher in those men who reported more sexual partners (P < 0.001 for all). In multivariable analysis, testing for gonorrhea was significantly more likely among non-Hispanic black versus white men (RR, 1.17; 95% CI, 1.03-1.33), among men seen in private versus public clinics (RR, 1.16; 95% CI, 1.05-1.28), and among men with 2 to 3 and 4 or more sexual partners versus 1 partner (RR, 1.12; 95% CI, 1.02-1.23, and RR, 1.18; 95% CI, 1.08-1.30, respectively). Correlates of chlamydia and syphilis testing were similar. Test positivity was higher among men with more sexual partners: for gonorrhea 0.0%, 3.0%, and 6.7% for men with 1, 2 to 3, and 4 or more partners, respectively (P < 0.001, syphilis 3.7%, 3.8% and 12.5%, P < 0.001). CONCLUSIONS: Among HIV-infected MSM patients in HIV care who reported sex without a condom, subsequent testing was not documented in clinic records during the following year for up to a quarter of patients. Exploring why STI testing did not occur may improve patient care.

In the United States, young people (ages 15-24 years) are disproportionately affected by human immunodeficiency virus (HIV) and other sexually transmitted diseases (STDs), due at least in part to inadequate or incorrect HIV/STD-related knowledge, attitudes, beliefs, and behavioral intentions (KABI). Comic book narratives are a proven method of HIV/STD prevention communication to strengthen KABI for HIV/STD prevention. Motion comics, a new type of comic media, are an engaging and low-cost means of narrative storytelling. The objective of this study was to quantitatively evaluate the effectiveness of a pilot six-episode HIV/STD-focused motion comic series to improve HIV/STD-related KABI among young people. We assessed change in HIV/STD knowledge, HIV stigma, condom attitudes, HIV/STD testing attitudes, and behavioral intentions among 138 participants in 15 focus groups immediately before and after viewing the motion comic series. We used paired t-tests and indicators of overall improvement to assess differences between surveys. We found a significant decrease in HIV stigma (p < .001) and increases in both HIV knowledge (p = .002) and behavioral intentions to engage in safe sex (p < .001). In summary, this motion comic intervention improved HIV/STD-related KABI of young adult viewers by reducing HIV stigma and increasing behavioral intentions to engage in safer sex. Our results demonstrate the promise of this novel intervention and support its use to deliver health messages to young people.

Due to the high burden of estimated annual deaths and hospitalizations associated with influenza epidemics in the United States [1, 2], annual influenza vaccination is recommended for persons aged ≥6 months, and for those who are at increased risk of influenza-related complications, including persons with human immunodeficiency virus (HIV) infections [3]. In 2011, we published data from the HIV Outpatient Study (HOPS), an open prospective HIV cohort study of HIV-infected outpatients seen in 9 well-established community-based private practices, public health clinics, and university-based clinics, describing annual rates of influenza vaccination among HIV-infected persons in care during influenza seasons from 1999 to 2008 [4]. We found that an average of 35% of HOPS participants received an influenza vaccination while under observation during the time period under investigation. This letter serves as an update to the previous analysis by including 5 years of additional data describing influenza vaccination rates among HOPS participants through 30 June 2013. | Among 6548 active patients (patients with at least 1 clinical encounter during the time period under investigation), 4788 were vaccinated at any time between 1 July 1999 and 30 June 2013. The annual vaccination rates ranged from a low of 26.4% to a high of 50.9% (average, 38.7%; linear regression trend P = .043; Figure 1) during the influenza seasons studied. The HOPS recorded the highest rate of vaccination during the 2009–2010 H1N1 influenza season, but that level was not sustained in subsequent seasons. Although we detected an overall temporal increase in influenza vaccination rates over the 14-year period, the observed rates continued to be consistently lower than published recommendations and below the goal of 70% set for Healthy People 2020 [3, 5], underscoring the need for improving adherence to guidelines for annual influenza vaccination for HIV-infected persons.

Biannual attendance at medical visits is an established measure of retention in HIV care. We examined factors associated with attending at least 2 clinic visits at least 90 days apart among HIV-infected, antiretroviral therapy (ART)-naive HIV Outpatient Study participants entering care during 2000 to 2011. Of 1441 patients, 85% were retained in care during the first year of observation. Starting ART during the year was the strongest correlate of retention (adjusted odds ratio [aOR] 6.4, 95% confidence interval [CI] 4.4-9.4). After adjusting for starting ART, publicly insured patients (aOR 0.6, 95% CI 0.4-1.0), and patients with baseline CD4 counts <200 cells/mm(3) (aOR 0.5, 95% CI 0.3-0.9) or missing CD4 counts (aOR 0.3, 95% CI 0.2-0.6) were less likely to be retained in care. Although most patients had recommended biannual care visits, some ART-naive individuals may require additional interventions to remain in care. Promptly initiating ART may facilitate engagement in care.

BACKGROUND: Recent US data on unsafe sexual behaviors among viremic HIV-infected men who have sex with men (MSM) are limited. METHOD: Using data abstracted from medical records of the participants in the HIV Outpatient Study (HOPS) and a supplemental behavioral survey, we assessed the frequency of high-risk sexual practices among HIV-infected MSM in care and examined the factors associated with risky sexual practices. We also compared the frequency of unprotected anal sex (UAS) with HIV-negative or unknown serostatus partners among viremic (HIV viral load ≥400 copies per milliliter) vs virologically suppressed (HIV viral load <400 copies per milliliter) MSM. RESULTS: Among 902 HIV-infected MSM surveyed, 704 (78%) reported having sex in the past 6 months, of whom 54% reported UAS (37% insertive, 42% receptive) and 40% UAS with a male partner who was HIV-negative or of unknown serostatus (24% insertive, 31% receptive). In multivariable regression with an outcome of engaging in any UAS with a male partner who was HIV-negative or of unknown serostatus, MSM aged <50 years, who reported injection drug use risk, had ≥2 sex partners, and who disclosed their HIV status to some but not to all of their sex partners were more likely to report this practice. Among MSM who reported any UAS, 15% were viremic; frequency of the UAS did not differ between viremic and virologically suppressed MSM. CONCLUSIONS: The high frequency of UAS with HIV-negative or unknown-status partners among HIV-infected MSM in care suggests the need for targeted prevention strategies for this population.

OBJECTIVE: To describe incidence of IRIS and its association with mortality in a large multi-site U.S. HIV-infected cohort applying an objective, comprehensive definition. DESIGN: We studied 2 610 patients seen during 1996-2007 who initiated or resumed highly active combination antiretroviral therapy (cART) and, during the next six months, demonstrated a decline in plasma HIV RNA viral load (VL) ≥ 0.5 log10 copies/mL or ≥ 50% increase in CD4 cell count/mm (CD4). We defined IRIS as the diagnosis of a Type B or Type C condition (per the CDC 1993 AIDS case definition) or any new mucocutaneous disorder during this same time period. METHODS: We assessed the incidence of IRIS, evaluated risk factors for IRIS using conditional logistic regression, and for all-cause mortality using proportional hazards models. RESULTS: We identified 370 cases of IRIS (in 276 patients). Median and nadir CD4 at cART initiation were 90 and 43 cells/mm, respectively; median VL was 2.7 log10 copies/mL. The most common IRIS-defining diagnoses were candidiasis (all forms), cytomegalovirus (CMV) infection, disseminated Mycobacterium avium intracellulare, Pneumocystis pneumonia, varicella zoster, Kaposi's sarcoma and non-Hodgkin lymphoma. Only one case of Mycobacterium tuberculosis was observed. IRIS was independently associated with CD4 < 50 cells/mm vs. ≥ 200 cells/mm (odds ratio [OR] 5.0) and VL ≥ 5.0 log10 copies vs. < 4.0 log10 copies (OR, 2.3). IRIS with a Type B or C-defining diagnosis approximately doubled the risk for all-cause mortality. CONCLUSION: In this large U.S.-based HIV-infected cohort, IRIS occurred in 10.6% of patients who responded to effective antiretroviral therapy, and contributed to increased mortality.

OBJECTIVE: Understanding mortality differences among HIV-infected patients can focus efforts to improve survival. DESIGN: We evaluated death rates, causes, and associated factors among treated patients in the HIV Outpatient Study (HOPS), a large, prospective, multicenter observational cohort of HIV-infected persons seen at a diverse set of US sites of care. METHODS: Among 3754 HOPS participants seen during 1996-2007 with at least 6 months of follow-up after initiating HAART and receiving HAART at least 75% of time under observation ('substantially treated'), we calculated hazard ratios for death using proportional hazards regression models. We also examined death causes and comorbidities among decedents. RESULTS: Substantially treated participants, followed a median 4.7 years (interquartile range, 2.2-8.5), experienced 331 deaths. In multivariable analyses, higher mortality was associated with an index CD4 cell count less than 200 cells/mcl [adjusted hazard ratio (aHR), 2.86; 95% confidence interval (CI) 1.95-4.21], older age (aHR, 1.50 per 10 years; 95% CI 1.33-1.70), log10HIV RNA (aHR, 1.67 per log10; 95% CI 1.51-1.85), but not race/ethnicity (aHR, 0.99 for blacks vs. whites, P = 0.92). Mortality was increased among publicly insured (PUB) vs. privately insured participants (PRV) when index CD4 cell count was at least 200 cells/mcl (aHR, 2.03; 95% CI 1.32-3.14) but not when index CD4 cell count was less than 200 cells/mcl (aHR, 1.3, P = 0.13). By death cause, PUB had significantly more cardiovascular events and hepatic disorders than PRV. Comorbidities more frequent among PUB vs. PRV decedents included cardiovascular disease, renal impairment, and chronic hepatitis. CONCLUSION: Among HAART-treated participants with CD4 cell counts at least 200 cells/mcl, PUB experienced higher death rates than PRV. Non-AIDS death and disease causes predominated among publicly insured decedents, suggesting that treatable comorbidities contributed to survival disparities.

BACKGROUND: It is unclear if CD4 cell counts at HIV diagnosis have improved over a 10-year period of expanded HIV testing in the USA. METHODS: We studied HOPS participants diagnosed with HIV infection ≤6 months prior to entry into care during 2000-2009. We assessed the correlates of CD4 count <200 cells/mm(3) at HIV diagnosis (late HIV diagnosis) by logistic regression. RESULTS: Of 1,203 eligible patients, 936 (78%) had a CD4 count within 3 months after HIV diagnosis. Median CD4 count at HIV diagnosis was 299 cells/mm(3) and did not significantly improve over time (P = 0.13). Comparing periods 2000-2001 versus 2008-2009, respectively, 39% and 35% of patients had a late HIV diagnosis (P = 0.34). Independent correlates of late HIV diagnosis were having an HIV risk other than being MSM, age ≥35 years at diagnosis, and being of nonwhite race/ethnicity. CONCLUSIONS: There is need for routine universal HIV testing to reduce the frequency of late HIV diagnosis and increase opportunity for patient- and potentially population-level benefits associated with early antiretroviral treatment.

BACKGROUND: We sought to describe rates of vaccination among HIV-infected adults in care and identify factors associated with vaccination. METHODS: Using data abstracted from medical records of participants in the HIV Outpatient Study (HOPS) during 8 influenza seasons (1999-2008) and negative binomial models with generalized estimating equation methods, we examined factors associated with increased prevalence of annual influenza vaccination. RESULTS: Among active patients, 25.8% to 43.3% were vaccinated for influenza each year (annual mean=35%, test for trend p=0.71). Vaccination rates peaked in October and November of each season and decreased sharply thereafter. Patients who were male (67.2%), non-Hispanic white (70%) or Hispanic (66%), had lower HIV viral loads (73.5%), were prescribed antiretroviral treatment (72.7%), or had attended a greater number of clinical encounters per year (86.7%) were more likely to receive influenza vaccination in multivariable analysis. DISCUSSION: The decreased likelihood of vaccination among women and non-Hispanic black patients suggests the need for focused efforts to reduce disparities. Increasing patient and clinician education on the importance of universal vaccination, and ensuring that vaccination activities continue in HIV clinics during the later months of the influenza season may improve influenza vaccine coverage.